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Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947661
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : May 30, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Open Angle Glaucoma
Ocular Hypertension
Interventions Drug: SPARC0912
Drug: Reference0912
Enrollment 578
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPARC0912 Reference0912
Hide Arm/Group Description SPARC0912 administered once daily for 12 weeks Reference0912 administered once daily for 12 weeks
Period Title: Overall Study
Started 289 289
Completed 276 274
Not Completed 13 15
Arm/Group Title SPARC0912 Reference0912 Total
Hide Arm/Group Description SPARC0912 administered once daily for 12 weeks Reference0912 administered once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 289 289 578
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 289 participants 289 participants 578 participants
63.1  (9.59) 63.8  (11.08) 63.4  (10.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 289 participants 578 participants
Female
186
  64.4%
188
  65.1%
374
  64.7%
Male
103
  35.6%
101
  34.9%
204
  35.3%
1.Primary Outcome
Title Change in Intraocular Pressure From Baseline to Week 12
Hide Description 95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population without LOCF
Arm/Group Title SPARC0912 Reference0912
Hide Arm/Group Description:
The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
[Not Specified]
Overall Number of Participants Analyzed 275 276
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
6.12  (0.23) 6.91  (0.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPARC0912
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was <1.5, and upper limit of 95% CI was <1 at most (at least 7 of 12) time point.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPARC0912 Reference0912
Hide Arm/Group Description SPARC's formulation administered once daily for 12 weeks Reference formulation administered once daily for 12 weeks
All-Cause Mortality
SPARC0912 Reference0912
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SPARC0912 Reference0912
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/289 (1.04%)      5/289 (1.73%)    
Eye disorders     
Macular edema   0/289 (0.00%)  0 1/289 (0.35%)  1
Gastrointestinal disorders     
Abdominal pain *  0/289 (0.00%)  0 1/289 (0.35%)  1
General disorders     
Colitis *  0/289 (0.00%)  0 1/289 (0.35%)  1
Chest pain *  1/289 (0.35%)  1 0/289 (0.00%)  0
Investigations     
Elevated blood pressure *  1/289 (0.35%)  1 0/289 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rotator cuff syndrome *  0/289 (0.00%)  0 1/289 (0.35%)  1
Back pain *  1/289 (0.35%)  1 0/289 (0.00%)  0
Renal and urinary disorders     
Renal failure *  0/289 (0.00%)  0 1/289 (0.35%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SPARC0912 Reference0912
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/289 (1.04%)      4/289 (1.38%)    
Gastrointestinal disorders     
abdominal pain, colitis   0/289 (0.00%)  2/289 (0.69%) 
General disorders     
Chest pain   1/289 (0.35%)  0/289 (0.00%) 
Investigations     
Blood pressure increased   1/289 (0.35%)  0/289 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain, Rotator cuff syndrome   1/289 (0.35%)  1/289 (0.35%) 
Renal and urinary disorders     
Renal failure   0/289 (0.00%)  1/289 (0.35%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Shravanti Bhowmik
Organization: Sun Pharma Advanced Research Company
EMail: shravanti.bhowmik@sparcmail.com
Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00947661    
Other Study ID Numbers: CLR_09_12
First Submitted: July 23, 2009
First Posted: July 28, 2009
Results First Submitted: December 14, 2015
Results First Posted: May 30, 2016
Last Update Posted: October 27, 2016